For a variety of reasons, many people desire to preserve reproductive material for future fertilization and implantation. For example, women cancer patients undergoing chemotherapy or radiation therapy often have a plurality of eggs aspirated from their ovaries and frozen in a cryobank in the event their eggs in ovaria become sterile. There are known, efficient techniques for aspirating eggs from human ovaries and for artificially fertilizing the eggs in a clinic. However, once extracted, known devices and methods for separating the individual eggs, blastocysts or embryos (hereinafter individually and/or collectively referred to as “human reproductive material”or “material”) from the fertilization dish and then storing the material are cumbersome and inefficient.
In the prior art, it is known to admit and freeze human reproductive material within open-ended, elongate cryostraws. Often, hundreds of such cryostraws are stored within a single cryotank. This method is potentially hazardous due to the risk of contamination from one egg/embryo to another within the tank. Recently, the FDA has mandated that cryobanks must store each material individually in sealed containers. Therefore, it is desirable to provide an apparatus and method for storing human reproductive material in individually-sealed containers to prevent the risk of contamination in a cryobank.
A known kit for individually separating and storing human reproductive material is sold by Irvine Scientific® under catalog no. 90133DE. The kit includes a cryostraw in which the material is admitted. However, one end of the cryostraw must first be connected to a flexible connection tube, which is provided in the kit. Then, the second end of the connection tube must be connected to a Hamilton syringe, which is not provided in the kit. This assembly is cumbersome to maneuver and requires two hands to assemble and to operate.
Another known kit for embryo cryopreservation is sold by Cryo Bio System (“CBS”) under the name CBS High Security Straw System (“HSSS”). This kit also requires assembly of a filing nozzle to the first end of the cryostraw and a connection nozzle to the second end. An aspiration apparatus (not provided) must then be connected to the connection nozzle via a flexible connection tube. This assembly is also cumbersome to maneuver and requires two hands to assemble and to operate. Therefore, it is desirable to provide a separation and storage apparatus that is pre-assembled, fully integrated, and can be operated using a single hand.
It is also very difficult to control displacement in the cryostraw of the above-described devices since the volume of the cryostraw is very small compared to the displacement volume of the Hamilton syringe and/or other aspiration apparatus. Even a small displacement of the aspiration apparatus produces a relatively large volumetric displacement in the cryostraw. Without tedious and careful control of the syringe, it is very easy to over admit the cryostraw. Therefore, it is desirable to provide a separation and storage apparatus that has precise volumetric-displacement control and can not be over admitted.
Once the human reproductive material is admitted to the cryostraw of the Irvine Scientific device or the CBS HSSS device, both ends must be heated sealed by contacting a heated surface. To heat seal the second end, the connection tube must be removed without disturbing or spilling the contents of the cryostraw. This procedure also requires two hands. Further, absent a glaring, visually-discernable defect in one of the seals, there is no practical way to confirm the integrity of each seal on the cryostraw. Therefore, it would be desirable to provide a separation and storage apparatus, which can be easily sealed and tested for seal integrity using a single hand.
Another cryopreservation kit, which is sold by CBS under the name High Security Vitrification Kit (“HSVK”), includes cryostraw, a capillary tube with a pre-formed gutter at one end and a handling rod at the other end, and a plastic insertion and removing device. The HSVK kit requires the technician to initially pick up the material using a micro-pipette and then to deposit the material onto the gutter of the capillary tube. The HSVK kit also has many of the same deficiencies as the above-described kits.